NorthStar Medical Technologies (NorthStar), a company involved in the development, production and distribution of radioisotopes for medical imaging and therapeutics, today provided a progress update on its actinium-225 (Ac-225) radioisotope program. Ac-225 is a high energy alpha-emitting radioisotope with potential therapeutic applications as a Targeted Alpha Therapy (TAT) for certain cancers and HIV. Because of limitations in current production technology, clinical research and commercial use of Ac-225 is severely constrained by chronic short supply. NorthStar is building upon previously completed proof of concept initiatives to progress towards commercial-scale production of Ac-225 and its daughter radioisotope, bismuth-213 (Bi-213).
“In line with our mission to deliver solutions for unmet needs in radioisotope development and production, NorthStar continues to progress our Ac-225 program,” said George Messina, Founder, Chairman and Chief Executive Officer. “Ac-225 is an under-utilized medical radioisotope with great potential in targeted therapy for patients with serious diseases such as acute myeloid leukemia (AML), infectious diseases such as HIV and potentially certain heart diseases such as atherosclerosis. However, clinical research is extremely limited due to availability of Ac-225. We believe that NorthStar is well-positioned to deliver innovative technology solutions to meet this challenge, as evidenced by the recent U.S. Food and Drug Administration approval of our novel RadioGenix™ System for producing technetium-99m from domestic, non-uranium based molybdenum-99. We intend to apply the same expertise and proven experience to advance Ac-225 commercial production. Pending successful development and FDA approval, RadioGenix technology may also have applications in using Ac-225 to produce the medical radioisotope Bi-213 for multiple therapies.”
“NorthStar has completed successful initial testing for Ac-225 production scale-up in collaboration with select institutions and laboratories,” said James T. Harvey, PhD, Senior Vice President and Chief Science Officer of NorthStar. “The process involves high energy proton irradiation of thorium targets to produce Ac-225. Further scale-up efforts are underway, to resolve Ac-225 and Bi-213 supply challenges, provide commercially relevant quantities of this important radioisotope and advance clinical research.”
About Targeted Alpha Therapy (TAT)
Targeted alpha-particle therapy (or TAT) is an investigational method of targeted radionuclide therapy for various cancers and infectious diseases. It employs radioactive alpha-emitting substances which undergo decay to treat diseased tissue at close proximity. TAT has the potential to provide highly targeted treatment, especially to microscopic tumor cells. Targets include leukemias, lymphomas, gliomas, melanoma, peritoneal carcinomatosis and HIV.
About Medical Radioisotopes –
Actinium-225 (Ac-225)/Bismuth-213 (Bi-213); Molybdenum-99 (Mo-99)/Technetium-99m (Tc-99m)
Actinium-225 (Ac-225) and its daughter isotope bismuth-213 (Bi-213) are high energy alpha emitting radioisotopes. They are attractive for medical purposes because they combine the ability to carry sufficient radiation energy to cause cell death in targeted cells with a sufficiently short half-life to limit unwanted radioactivity in patients. Ac-225 and Bi-213 are the mainstays for preclinical and clinical studies of targeted alpha therapy and have been identified as optimal TAT radioisotopes. However, current supply of Ac-225 is severely constrained and can only meet demand for a very limited number of patients annually. NorthStar is developing a proprietary process for commercial-scale production of Ac-225 to meet demand for clinical research and treatment.
Tc-99m is a radioisotope used in a variety of diagnostic testing procedures. It is currently the most widely used medical radioisotope in the United States, used in more than 10 million diagnostic procedures annually. Tc-99m-based radiopharmaceuticals are used to diagnose and stage heart disease, cancer, infection, inflammation and other conditions.
Tc-99m is derived from the radioisotope Mo-99. The United States uses about 50% of the world’s Mo-99/Tc-99m for medical purposes, but U.S. supply of Mo-99 has been completely reliant on foreign sources and subject to frequent and sometimes protracted interruptions which have the potential to negatively impact patient healthcare. Other Mo-99 producers continue to use enriched uranium in their processing which poses significant environmental concerns. NorthStar’s technology uses stable isotopes of molybdenum to produce Mo-99 domestically without incurring many of the concerns related to the management of toxic waste associated with Mo-99 production from enriched uranium.
About NorthStar Medical Technologies, LLC (NorthStar)
NorthStar Medical Radioisotopes, founded in 2006 and based in Beloit, Wis., and NorthStar Nuclear Therapies, LLC are wholly-owned subsidiaries of NorthStar Medical Technologies, LLC. NorthStar is a nuclear medicine technology company committed to providing the United States with reliable and environmentally friendly radioisotope supply solutions to meet the needs of patients and to advance clinical research. The Company’s first product is the RadioGenix™ System, an innovative and flexible platform technology initially approved by the U.S. Food and Drug Administration in February 2018 for the processing of non-uranium/non-highly enriched uranium based molybdenum-99 (Mo-99), the parent isotope of technetium-99m (Tc-99m), which is currently the most widely used diagnostic radioisotope for medical purposes. NorthStar’s proprietary and patented technologies include non-uranium based molybdenum-99 domestic production methods, patented separation chemistry systems, patented sterilization systems and a technology platform that potentially allows expanded product offerings to provide solutions in both the diagnostic and therapeutic markets. For more information, visit: www.northstarnm.com
Indication and Important Risk Information About the RadioGenix™System and Sodium Pertechnetate Tc 99m Injection USP
The RadioGenix™ System is a technetium Tc-99m generator used to produce Sodium Pertechnetate Tc 99m Injection, USP. Sodium Pertechnetate Tc 99m Injection is a radioactive diagnostic agent and can be used in the preparation of FDA-approved diagnostic radiopharmaceuticals.
Sodium Pertechnetate Tc 99m Injection is also indicated in
- Adults for Salivary Gland Imaging and Nasolacrimal Drainage System Imaging (dacryoscintigraphy).
- Adults and pediatric patients for Thyroid Imaging and Vesicoureteral Imaging (direct isotopic cystography) for detection of vesicoureteral reflux.
IMPORTANT RISK INFORMATION
- Allergic reactions (skin rash, hives, or itching) including anaphylaxis have been reported following the administration of Sodium Pertechnetate Tc 99m Injection. Monitor all patients for hypersensitivity reactions.
- Radiation risks associated with the use of Sodium Pertechnetate Tc 99m Injection are greater in children than in adults and, in general, the younger the child, the greater the risk owing to greater absorbed radiation doses and longer life expectancy. These greater risks should be taken firmly into account in all benefit-risk assessments involving children. Long-term cumulative radiation exposure may be associated with an increased risk of cancer.
- Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for 12 to 24 hours after Sodium Pertechnetate Tc 99m Injection administration.
- Sodium Pertechnetate Tc 99m Injection should be given to pregnant women only if the expected benefits to be gained clearly outweigh the potential hazards.
- Only use potassium molybdate Mo-99, processing reagents, saline and other supplies, including kits, provided by NorthStar Medical Radioisotopes. Do not administer Sodium Pertechnetate Tc 99m Injection after the 0.15 microCi of Mo-99/mCi of Tc-99m limit has been reached or when the 12 hour expiration time from elution is reached, whichever occurs earlier.
To report SUSPECTED ADVERSE REACTIONS, contact NorthStar Medical Radioisotopes, LLC at 1-844-438-6659; or FDA at 1-800-332-1088 or www.fda.gov-/medwatch.
For Full RadioGenix™ System Prescribing Information, click here or visit https://www.northstarnm.com/wp-content/uploads/2018/04/PI_Rev04_23mar2018.pdf.